Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-8593 |
| Trade Name | Dose Form | Strength | Identifier |
| Naltraccord | Film coated tablet | 50 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Teva Pharma (New Zealand) Limited P O Box 128 244 Remuera Auckland 1541 | 21/6/2010 | Consent given Approval date: 2/12/2010 | Prescription |
| Reference product: ReVia Film coated tablet 50 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Naltrexone hydrochloride 50mg | Sanofi Chimie Route D'Avignon Aramon F-30390 FRANCE | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Crospovidone | ||
| Lactose monohydrate | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry yellow YS-1-6378G |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Manufacture of Final Dose Form | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Packing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| NZ Site of Product Release | Teva Pharma (New Zealand) Limited Level 14, 41 Shortland Street Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/PE/Aclar-Al or Al-Al | 14 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/PE/Aclar-Al or Al-Al | 28 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/PE/Aclar-Al or Al-Al | 30 tablets | 36 months from date of manufacture stored at or below 25°C |
Indications
Naltraccord is indicated for use within a comprehensive treatment programme for alcohol dependence.
Naltraccord is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 26/10/2023 | Changed Medicine Notification | Finished product specifications/test methods - G3 | Granted 6/12/2023 | 2/11/2023 | |
| 21/6/2010 | New Intermediate-risk Medicine Application | Abridged new intermediate-risk prescription medicine | Granted 2/12/2010 | 24/6/2010 |
